DOSAGE PREPARATION: the test item was weighed out into a tared plastic vial on a precision balance. Homogeneity was maintained by vortexing. The dosages were made shortly before administration.

CLASS METHOD- Rationale for the selection of the starting dose: no details provided

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 females twice (6 females in total)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of weighing: the animals were weighed on day 1 (prior to the administration), on day 8 (1 week thereafter) and on day 15 (2 weeks thereafter)- Frequency of observations: a careful clinical examination was made several times on the day of dosing (at least once during the 1st 30 minutes and with special attention given during the 1st 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. According to the OECD Guideline.- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities occurred

Mortality:

- No mortalities occurred

Clinical signs:

- At 3 and 4 hours after administration, slight to moderate reduced spontaneous activity, prone position and piloerection was observed in the 3 animals of the 1st group, until day 2- No other signs were observed in any of the animals at any observation time

Body weight:

- No abnormalities were observed. The animals had a weight gain of 18 to 30% during the observation period

The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles. The substance was dosed in cotton seed oil at 2 g/kg bw in 6 female rats, in 2 steps. At 3 and 4 hours after administration, slight to moderate reduced spontaneous activity, prone position and piloerection was observed in the 3 animals of the 1st group, until day 2. No mortalities occurred. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.

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